HIBSAGO (Bepirovirsen) Injection

HIBSAGO (bepirovirsen), from GSK, is an antisense oligonucleotide (ASO) approved in Japan as a functional cure for chronic hepatitis B (CHB) virus infection in adult patients who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers.

Bepirovirsen is designed to recognise and inhibit the production of hepatitis B virus RNA, reducing viral proteins and hepatitis B surface antigen (HBsAg) in the blood and stimulating the immune system to help achieve a durable, sustained response. In the pooled B-Well 1 and B-Well 2 Phase 3 trials, 6 months of treatment achieved functional cure in 19% of adults with HBsAg of 3000 IU/ml or below (233 of 1,220, versus 0 of 614 on placebo), and in 26% of those with HBsAg of 1000 IU/ml or below (200 of 768, versus 0 of 393 on placebo). Functional cure means HBsAg and hepatitis B virus DNA remain undetectable for at least 24 weeks after stopping all treatment.

• In the B-Well Phase 3 trials, the most frequently observed adverse events were injection site erythema, local pain, and a temporary rise in the blood level of a liver enzyme.
• HIBSAGO is approved for adults who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral marker criteria; it should be prescribed and monitored by a specialist.
• HIBSAGO is currently approved in Japan only (US regulatory decision pending), so the full prescribing information from the approving regulator should be reviewed before treatment.

What documents are required to import HIBSAGO to India?

HIBSAGO may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered hepatologist or gastroenterologist
• Diagnostic report confirming chronic hepatitis B, HBsAg level, and prior nucleos(t)ide analogue therapy
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is HIBSAGO available in India?

HIBSAGO was approved in Japan in August 2026 (its first global approval) and is not yet commercially available in India. It can be legally accessed through the Named Patient Program (NPP), subject to applicable regulations.

Indian Pharma Network (IPN) can source HIBSAGO from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For HIBSAGO cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• Japan: Approved by the Ministry of Health, Labour and Welfare (MHLW) — August 24, 2026 (SENKU designation).
• United States: Under FDA review (Fast Track and Breakthrough Therapy designations); decision expected in the coming months.

What is HIBSAGO used for?

HIBSAGO is approved in Japan as a functional cure for chronic hepatitis B in adults who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers.

Who manufactures HIBSAGO?

HIBSAGO is developed by GSK, which licensed bepirovirsen from Ionis Pharmaceuticals.

How does HIBSAGO work?

It is an antisense oligonucleotide that inhibits production of hepatitis B virus RNA and viral proteins, lowering HBsAg and helping the immune system regain control of the infection.

What is a functional cure for hepatitis B?

Functional cure means hepatitis B virus DNA and HBsAg stay undetectable for at least 24 weeks after all treatment is stopped, indicating the immune system is controlling the disease without medication.

Is HIBSAGO approved by the US FDA?

Not yet. Japan issued the first global approval on August 24, 2026; the US decision is expected in the coming months.

How much does HIBSAGO cost in India?

Cost depends on treatment duration and sourcing logistics — share your prescription with IPN for a quote.